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| CFDA director: GMP, GSP certification will be cancelled! |
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| Author：中国铭铉 企划部 Release Time：2017-9-27 11:09:09 Number Browse：1757 |
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The medical network on September 26 no longer has to be the heart of the GSP certification.
CFDA director: GMP, GSP certification will be cancelled
"GMP, GSP certification will be cancelled." Ding jianhua, director of the supervision department of the food and drug administration at the 2017 Chinese pharmaceutical entrepreneurs' meeting in Beijing, September 24, 2016.
There were calls from the industry for the general assembly to make a sound, and the total cancellation of GSP certification was taken.
At the conference's policy innovation conference, Mr Ding expressed the need to cancel the GMP, GSP certification and the relationship between the company and the company: "the flaws are true and the 100 per cent is fake. The transition from certification to inspection is a challenge for both companies and us. Our future relationship with the company is that I am not a police officer and you are not a thief. We are a cooperative relationship. Only the final goal can be achieved, otherwise it will not be possible."
GMP/GSP is the minimum requirement and the flight test will be more
As early as 2014, held in November 26th national medicine economic information release, the Wu Li of legal department in the pharmaceutical administration law revised orientation report includes: gradually cancel drug GMP and GSP certification system, and put down the access standards, certification system and medicine enterprises and daily regulation of production and management, reduce the examination and approval regulation, strengthen the daily supervision and inspection.
The meeting on September 24th, the blue - parker pharmacy managers (WeChat ID: yaod366) with such a problem to jian-hua ding proof: cancel the GMP/GSP certification, does that mean more strict regulation, after flying inspection more frequent?
He quipped, "why do you want to cancel, how many people agree to cancel, raise your hand?"
Many people raised their hands in favour of cancellation. Someone replied, "it's too much trouble to cancel because the certification process..." A word provoked the conference hall to laugh.
At the same time, some people on the scene suggested that the certification should be kept for the enterprise to have a standard to do, as a guideline.
Jian-hua ding's answer is clear: "think of the cancellation, don't think to cancel the agency finally come to find me, you must be do more than dream), on the contrary, look more, find a more scientific."
"GMP/GSP is the floor (should not be seen as a high standard ceiling), is the minimum standard, is the minimum requirement, so no certification is required."
In fact, the objective reason for not requiring certification is that there are not many companies that have reached the GMP/GSP standard before, and now everyone is doing so, and the standard is surpassed. It's a luxury to eat white bread, but now everyone can eat it.
Therefore, GMP/GSP is the most basic and minimal configuration.
There's no need to send a good person to the good guy. He'll do it well
An undeniable fact is that, in the development of Chinese medicine industry for almost 20 years to tell, if there is no GMP/GSP, without the efforts of the enterprise, the current level of the pharmaceutical industry can not meet the current level. And development means change, so the idea of GMP and GSP needs to change. Eliminating the two is one of the manifestations of this "change".
For example, the current concept of many drugs and medical device manufacturers is that after selling the products to the first and second level wholesalers, it will be ok with them. Or, after GMP certification and testing are passed, the product works.
"A lot of people don't connect the quality of the product to the patient, and the medicine is for the sake of healing." Jian-hua ding did a very image of the parable: "the GMP (GSP) should be the floor instead of the ceiling, there is no need to send the good one" good certificate "(prove that he is a good man), to do is should, in accordance with the requirements of GMP is should."
GSP certification should not be like the university of college, which is exciting for a while, and "sheep" for four years
Analogy: there is no need to issue a GSP certificate to the medical device circulation enterprise to prove that the medical device he sells is qualified. Conformity is the most basic requirement, not the time of certification. This is the idea that current medical device circulation enterprise should have.
It's like college. After three years of high school, once the ivory tower entered the university, I relaxed myself and even wasted my study, thinking that I would be ok in college. Although at the end of the day get the graduation certificate, but not the weight, but actually because of the university as a ceiling standard.
In fact, after the fact that it is not certified, the business is more worried because you don't know which day to check, you have to do it every day, and you will find yourself on your head every day.
Compared to before, the responsibility of the enterprise is big, it is a good thing that is more conducive to enterprise growth. Instead of checking it out today, I will be relieved to have a sigh of relief tomorrow evening. The chairman of the board said that the bonus will be paid for dinner, and then he will be separated for five years.
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